Ostomy appliances and wound drainage devices hereinafter collectively referred to as ostomy appliances generally include a bag or pouch for collecting bodily wastes discharged from their surgically created stoma. The bag is connected to a pad or surgical dressing which is in contact with the patient's skin and surrounds the stoma.
Most ostomy appliances employ a coupling between the bag and the dressing which enables the bag to be readily removed when necessary, and replaced by a clean, empty bag. The coupling should provide a fluid tight seal to prevent leakage of liquids and/or gases.
Coupling systems are known in the art for reversibly securing the principal components of the ostomy appliance to each other. Such systems are disclosed, for example, in Peter L. Steer et al, U.S. Pat. Nos. 4,232,672; 4,460,363; and 4,518,389, Peter L. Steer, U.S. Pat. Nos. 4,636,205; 4,710,183; and 4,701,169, Keith T. Ferguson, U.S. Pat. No. 4,648,875 and Ronald Arnone et al, U.S. Pat. No. 4,642,107, each incorporated herein by reference.
Each of these systems relies on a mechanical coupling system to secure the ostomy bag to the dressing surrounding the stoma. Mechanical coupling devices, however, are prone to leakage because the contacting faces thereof eventually move out of face to face alignment. This occurs as a result of prolonged use of the device, changes in temperature and from manufacturing defects. It should also be noted that as the diameter of the mechanical coupling device increases, the security of the device generally decreases. Specifically, the larger diameter devices are more susceptible to being dislodged when the patient moves.
Ostomy appliances generally adhere to the patient's skin through the use of an adhesive. The adhesives are typically pressure sensitive and may contain additives which have soothing and/or healing properties to minimize patient discomfort during use of the ostomy appliance. For example, James L. Chen et al, U.S. Pat. No. 4,253,460, incorporated herein by reference, discloses an adhesive composition composed of a hydrocolloid gum, a pressure sensitive adhesive and a cohesive strengthening agent, optionally including pectin and gum karaya. Other examples of adhesive compositions for this use are disclosed in Arthur Doyle et al, U.S. Pat. No. 4,551,490 and John M. Pawelchak et al, U.S. Pat. No. 4,393,080, each incorporated herein by reference. Included among the disclosed adhesive compositions is a homogenous blend of mineral oil, at least one polyisobutylene alone or with an elastomer such as styrene radical or block type copolymers. The styrene copolymers include commercially available products sold by Shell Chemical Company under the tradename Kraton.
More recently an ostomy appliance has been sold under the trademark Microskin by Cymed, Inc. of Hayward, Calif. This device employs an adhesive to join facing surfaces of the respective coupling components. The coupling components are separated from each other by disrupting the adhesive seal and then attaching a new coupling device including a fresh ostomy bag. When the seal is broken the respective adhesive surfaces often have attached thereto particles of waste products that must be removed before a new ostomy bag can be added. After cleaning respective surfaces must be substantially free of all contaminants to prevent infection.
Conventional adhesives such as employed in the Microskin product are disadvantageous. Although such adhesives may be washable, they have an adhesive quality in which the adhesive sticks to patient preferred cleaning implements employed by the patient to clean the coupling surfaces such as tissues, cloths and the like. The conventional adhesive compositions typically retain small particles of fibers from such cleaning implements and therefore cannot provide a contamination free surface for attachment of the next ostomy bag. In addition, such products employ a silicon release paper which is difficult to separate from the adhesive layer, especially for elderly patients.
In order to avoid this problem such prior devices require organic solvents to clean the coupling surfaces and must be dried without the convenience of using patient preferred cleaning implements.
Applicant has discovered that adhesive compositions can be employed to couple the principal components of an ostomy appliance together so as to eliminate the need for mechanical coupling devices. Such devices can provide a fluid tight seal that may be unsealed to replace the used ostomy bag with a new one and then resealed in fluid tight fashion. The problem of leakage of liquids and/or gases characteristic of ostomy appliances relying on mechanical seals can therefore be eliminated or at least minimized.
In addition, the present invention provides an adhesive coupling system that can provide a clean surface for the reapplication of a new ostomy bag using conventional cleaning implements.